Assessment of the Different Etiological and Susceptibility Markers in Patients With Pancreatitis: Investigating IG4, Cytomegalovirus, Coxsackie- Virus, Genetic Polymorphism of Vitamin D Receptor Gene

NCT ID: NCT03830073

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-06-20

Brief Summary

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Acute pancreatitis (AP) is a multifactorial disease. AP represents a significant number of hospital admissions. Most of the patients are admitted in an acute setting. Early identification of its etiology is an essential step toward the rational approach, both for its implications in the immediate therapy and the prevention of recurrence. Although often obvious, the etiological workup of acute pancreatitis can be challenging.

Detailed Description

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Acute pancreatitis is the most common pancreatic disorder. Although acute pancreatitis is a benign disease, it often progresses to a serious state, and mortality is still high. Autoimmune pancreatitis (AIP) was first used to describe cases of pancreatitis with narrowing of the pancreatic duct, enlargement of the pancreas, hyper-γ-globulinaemia, and antinuclear antibody (ANA) positivity serologically by indirect immunofluorescence (IIF). The main differential diagnosis is pancreatic cancer, which can be ruled out through radiological, serological, and histological investigations.

Cytomegalovirus (CMV) is a common viral pathogen in humans. It is a lytic virus that causes a cytopathic effect in vitro and in vivo. Seroprevalence for CMV worldwide ranges from 60%-100% but the severity of illness varies. Primary CMV may be asymptomatic or may cause a mild and self-limiting mononucleosis-like syndrome. The self-limiting course of CMV infection typically includes fever, malaise, splenomegaly, mild hepatomegaly, small increases in serum transaminase activity, and variable elevation of serum alkaline phosphatase. CMV infection can cause severe hepatitis, meningitis, encephalitis, myelitis, colitis, pancreatitis and pneumonitis. Coxsackie-B virus can also cause acute pancreatitis.

VDR are also expressed on pancreatic Ɓ cells, and may play an essential role in maintaining normal insulin levels in accordance to glucose concentrations and to maintain glucose tolerance. Because vitamin D acts through VDR, their impairment or reduced functionality, e.g., as a result of polymorphisms occurring in the VDR gene, may have a crucial impact on the balance in the vitamin D concentration in the circulation, and the final metabolite activity throughout the body.

Conditions

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Acute Pancreatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group I:

Seventy patients with pancreatitis

Measurement of VDR genetic polymorphism

Intervention Type GENETIC

VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.

Group II:

Thirty healthy controls

Measurement of VDR genetic polymorphism

Intervention Type GENETIC

VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.

Interventions

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Measurement of VDR genetic polymorphism

VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Patients with a confirmed diagnosis of acute pancreatitis.
* Patients of age 20 years or more who are willing to participate in the study and give their consent for same.

Exclusion Criteria

* with a history of severe liver disease,
* sepsis
* Chest disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Reham I El-mahdy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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reham elmahdy

Role: CONTACT

+201002714637

References

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Cieslinska A, Kostyra E, Fiedorowicz E, Snarska J, Kordulewska N, Kiper K, Savelkoul HFJ. Single Nucleotide Polymorphisms in the Vitamin D Receptor Gene (VDR) May Have an Impact on Acute Pancreatitis (AP) Development: A Prospective Study in Populations of AP Patients and Alcohol-Abuse Controls. Int J Mol Sci. 2018 Jun 29;19(7):1919. doi: 10.3390/ijms19071919.

Reference Type BACKGROUND
PMID: 29966312 (View on PubMed)

Chan A, Bazerbachi F, Hanson B, Alraies MC, Duran-Nelson A. Cytomegalovirus hepatitis and pancreatitis in the immunocompetent. Ochsner J. 2014 Summer;14(2):295-9.

Reference Type BACKGROUND
PMID: 24940147 (View on PubMed)

Shimizu K, Tahara J, Takayama Y, Akao J, Ajihara T, Nagao K, Shiratori K, Tokushige K. Assessment of the Rate of Decrease in Serum IgG4 Level of Autoimmune Pancreatitis Patients in Response to Initial Steroid Therapy as a Predictor of Subsequent Relapse. Pancreas. 2016 Oct;45(9):1341-6. doi: 10.1097/MPA.0000000000000633.

Reference Type BACKGROUND
PMID: 27171510 (View on PubMed)

Ozsvar Z, Deak J, Pap A. Possible role of Coxsackie-B virus infection in pancreatitis. Int J Pancreatol. 1992 Apr;11(2):105-8. doi: 10.1007/BF02925981.

Reference Type BACKGROUND
PMID: 1318913 (View on PubMed)

Other Identifiers

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Autoimmune pancreatitis

Identifier Type: -

Identifier Source: org_study_id

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